Vanguard Clinical, Inc.

• The Clinical Operations Specialist (COS) is an experienced, cross-functional clinical research professional responsible for supporting and driving key operational activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF) Management, Data Management, Vendor Oversight, Site Support, and broader study execution. • Lead administrative and operational coordination across the clinical trial lifecycle. • Independently manage study trackers, site updates, enrollment metrics, and operational reporting. • Prepare agendas, lead or co-lead portions of meetings, and finalize high-quality minutes and action items. • Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams. • Provide proactive solutions and anticipatory support to internal teams and Sponsor clients. • Independently manage essential document collection, QC, and readiness for site activation. • Conduct feasibility outreach, site qualification support, and site-level intelligence collection. • Lead start-up timeline tracking and drive accountability with sites and vendors. • Perform advanced QC review for TMF documents and root-cause identification for recurring issues. • Independently manage TMF filing, metadata application, and cross-checking for document dependencies. • Support audit/inspection readiness, including TMF remediation, reporting, and corrective action follow-up. • Perform high-level clinical data review in EDC systems; generate and track complex queries.

• Reporting to the Director - Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites. • The Clinical Research Associate (CRA) will execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs). • Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits. • Main point of contact between assigned sites and Sponsor. • Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements. • Delivers high quality and timely reports following each monitoring visit. • Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines. • Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites. • Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites. • Manages query resolution process with clinical sites and data management groups. • Travel of up to 75% may be required, including globally. Quarterly travel to San Diego headquarters required, if not residing locally. • Other work-related duties, special projects, and/or other functions, as required.

• Reporting to the Director, Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites • The Senior Clinical Research Associate (Sr. CRA) will independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs) • Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits • Main point of contact between assigned sites and Sponsor • Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements • Delivers high quality and timely reports following each monitoring visit • Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines • Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites • Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites • Manages query resolution process with clinical sites and data management groups • Travel of up to 75% may be required, including globally • Quarterly travel to San Diego headquarters required, if not residing locally.

• Provides independent quality oversight of internal and external clinical trial activities, records, and processes to ensure compliance with FDA regulations, ICH-GCP, internal SOPs, and other applicable regulatory requirements. • Supports quality objectives across the organization and contributes to achieving departmental and company goals. • Maintains current knowledge of applicable GxP requirements and regulatory developments and communicates relevant impacts to QA leadership and stakeholders. • Supports the implementation, maintenance, and ongoing oversight of the Quality Management System (QMS). • Develops, reviews, and maintains SOPs and quality documentation to ensure compliance with applicable regulatory requirements (ICH-GCP, FDA CFR, etc.). • Provides client-facing Quality Assurance support, including development of quality documentation (e.g., SOPs, plans) and regulatory compliance guidance. • Establishes and maintains appropriate quality standards, parameters, and controls across clinical programs and quality processes. • Ensures ongoing compliance with applicable federal, state, local, and organizational regulations, guidelines, and policies. • Implements and supports Clinical Quality Assurance plans aligned with GCP standards, internal policies, and procedures. • Leads and supports inspection and audit readiness activities, including preparation, coordination, and participation in regulatory agency inspections. • Plans, conducts, and/or supports qualification, routine, and for-cause audits, and participates in the evaluation, qualification, and ongoing oversight of clinical vendors in accordance with company SOPs. • Oversees the management, tracking, and effectiveness of audit observations and CAPAs, including root cause analysis, trending, and escalation of systemic quality issues. • Evaluates quality trends and metrics to identify risks, support continuous improvement, and informs QA reporting to management. • Provides QA guidance to cross-functional teams through participation in study team meetings and interpretation of current regulatory requirements and best practices. • Conducts or supports QA review of clinical and regulatory documents, including protocols, Investigator Brochures, Clinical Study Reports, and integrated summaries, as applicable. • Supports the development and delivery of training materials and provides GCP and SOP-related training to internal stakeholders. • Collaborates with clinical teams to assess and investigate temperature excursions, deviations, and product complaints reported from clinical sites. • Participates in QA budget planning and resource forecasting activities. • Develops, monitors, and reports GCP quality metrics to support consistent quality performance across the organization. • Performs other duties and special projects as required.

• Develop and generate new business development leads. • Work with targeted business development accounts to secure future business. • Develop and implement projects, programs and strategies to accomplish corporate objectives. • Develop materials and presentations demonstrating CRO services according to client specifications and needs. • Prepare and/or assist in the preparation of price quotations, terms of sale and timelines according to company policy and within corporate guidelines. • Monitor monthly time and activity versus productivity to assess and implement continuous improvement. • Interview prospective new team members. • Supervise and conduct employee training/continuing education and performance evaluations. • Other duties as assigned.

• Provide administrative and operational support across the clinical trial lifecycle. • Track study metrics (enrollment, screening, recruitment, site updates). • Assist in preparing and documenting meeting materials. • Schedule and coordinate meetings. • Prepare, ship, and track investigational products and study supplies. • Support collection, tracking, and review of essential documents. • Assist with feasibility, qualification, and regulatory document management. • Support IRB/EC submissions and ICF preparation. • Track study start-up timelines and follow up with sites and vendors. • Perform QC review of TMF documents. • File documents per TMF Reference Model. • Identify gaps, inconsistencies, and missing documentation. • Support audit and inspection readiness. • Review and enter clinical data into EDC systems. • Manage data queries, reconciliation, and quality control checks. • Support documentation review and source verification activities. • Provide customer service to clients, vendors, and sites. • Draft or update trackers, presentations, and study reference materials. • Support cross-functional initiatives and process improvements. • Participate in study meetings and assist with follow-up actions.